The expanding landscape of GLP-1 drugs: What's next in the race for new treatments?
A deep dive into the latest GLP-1 clinical trials and the companies behind them
In the last article on glucagon-like peptide-1 (GLP-1) receptor agonists, I discussed the soaring demand for drugs like Ozempic, Wegovy, and Zepbound and how they work in the human body. Initially developed for type 2 diabetes, these medications have gained a ton of attention for their weight loss benefits, leading to supply shortages and a surge in demand for compounded GLP-1s from pharmacies.
Meanwhile, the massive success of Eli Lilly and Novo Nordisk has inspired other pharma companies to invest in their own weight loss treatments. A recent report by Morningstar expects as many as 16 new GLP-1 drugs to hit the market by 2029, potentially capturing close to one-third of a projected $200B market by 2031. Eli Lilly and Novo Nordisk are predicted to cover the remaining two thirds of the GLP-1 market by 2031, with weight-loss treatments making up about 68% of their sales.
Pharmaceutical companies are also exploring innovative formulations and delivery methods such as oral pills to enhance the efficacy and convenience of GLP-1 treatments, with the market poised for significant expansion in the coming years.
The excitement surrounding GLP-1 therapies is intensifying as their therapeutic potential extends far beyond diabetes and obesity. Currently approved for type 2 diabetes, chronic weight management, and reducing cardiovascular risk in obese patients, these drugs are now being tested for a range of other conditions. Ongoing trials are exploring their use in non-alcoholic fatty liver disease (steatohepatitis), cardiovascular diseases in non-diabetic individuals, Alzheimer’s, and chronic kidney disease.
In this post, I explore the most promising GLP-1 drugs currently advancing through clinical trials and highlight the companies developing them—beyond the two giants, Lilly and Novo.
🔸 Amgen’s promising candidate MariTide could reshape the GLP-1 market
Amgen’s stock appears fairly valued at 17x next year’s earnings, supported by a robust and diversified portfolio of existing products which are driving significant revenue for the company. However, analysts argue that the potential success of Amgen’s GLP-1 candidate, MariTide (formerly known as AMG 133), is not yet fully reflected in the stock price.
MariTide shows promise in the GLP-1 market due to its long-lasting effects and less frequent dosing, which could address current market shortages and provide a significant upside if it continues to perform well in clinical trials.
MariTide has completed phase 1 studies, demonstrating exceptional pharmacokinetics with a half-life of 14-25 days, allowing for monthly dosing. This is a key advantage over current GLP-1 drugs like Ozempic and Wegovy, which require weekly injections. The potential for less frequent dosing not only differentiates MariTide but could also alleviate supply issues tied to injector shortages. Amgen’s strategy to improve the existing injectable GLP-1 drugs without switching to a riskier oral form could capture significant market share if approved.
As of September 5, Amgen is advancing MariTide into a broad phase 3 program to assess its potential in addressing related conditions like heart, kidney, and liver diseases. Speaking at the Morgan Stanley Global Healthcare Conference, Amgen CEO Robert Bradway highlighted MariTide’s unique mechanism, which activates the GLP-1 receptor while blocking the GIP receptor, potentially offering longer-lasting effects with less frequent dosing.
🔸 J.P. Morgan bets big on Viking
On September 11, J.P. Morgan initiated coverage of Viking Therapeutics (VKTX) with an “Overweight” rating and an $80 price target. The firm expressed strong optimism around Viking’s oral obesity therapy, VK2735, highlighting its promising efficacy and minimal gastrointestinal side effects at low doses. J.P. Morgan pointed to the upcoming phase 1 data readout at Obesity Week in November as a key catalyst, expecting higher doses of VK2735 to demonstrate even better results. With potential to capture ~10% of the U.S. oral obesity drug market, an area currently untapped by Novo Nordisk and Eli Lilly, VK2735 could position Viking as a major player in the GLP-1 market.
J.P. Morgan also placed Viking under a “positive catalyst watch,” anticipating a significant stock movement following the November data presentation. The firm expects oral GLP-1 drugs to play an increasingly important role in the obesity market.
Beyond VK2735, Viking’s pipeline includes VK2809 for non-alcoholic steatohepatitis and VK0214 for X-linked adrenoleukodystrophy, both progressing well in clinical trials.
🔸 Roche’s $2.7B bet on obesity yields average results so far
Roche (RHHBY) is another company with an expanding portfolio of weight loss drugs. In January 2024, the company acquired Carmot Therapeutics for $2.7B, with potential additional payments of up to $400M based on milestone achievements.
This acquisition granted Roche access to Carmot’s three key drug candidates: CT-388, a dual GLP-1/GIP receptor agonist for obesity; CT-996, an oral GLP-1 receptor agonist for obesity; and CT-868, a dual receptor agonist for type 1 diabetes.
However, the results of CT-388 and CT-996’s clinical trials have been somewhat underwhelming. Shares of Roche fell 4.5% on September 9 after side effect details of CT-388 were prematurely released, including nausea, vomiting and diarrhea. In response, Hans Clevers, Roche’s head of pharma research said the company was “not alarmed at all” about the side effects, describing CT-388 as comparable to other drugs in its class, noting that no patients discontinued the treatment due to side effects.
Roche’s other obesity candidate, CT-966, was expected to be the leading option. On September 11, at the European Association for the Study of Diabetes Annual Meeting, Roche presented detailed early-phase results for CT-966. While the data from an initial trial showed encouraging outcomes, they were derived from just six patients, leaving some uncertainty about the drug’s future development. At the conference, Roche acknowledged that more extensive trials are needed to fully assess CT-966’s potential as a leading obesity treatment.
🔸 Structure Therapeutics — an overlooked player in the GLP-1 market
Stucture Therapeutics (GPCR) is an emerging player in the GLP-1 weight loss market. Structure’s stock has surged a few times in the past couple of months, and the company has a strong cash position and a diverse pipeline. The company’s lead candidate, GSBR-1290, is another oral GLP-1 receptor agonist, which could offer a competitive advantage over injectable therapies like semaglutide and tirzepatide.
Initial phase 1 and 2a trials showed promising weight loss and a strong safety profile, making it a standout among other oral candidates. GSBR-1290 showed a statistically significant, placebo-adjusted mean weight loss of 6.2% at 12 weeks and favorable safety, with low rates of discontinuation due to adverse events.
Structure is also working on other obesity drugs, including amylin receptor agonists and other GLP-1/GIPR combinations, and APJ receptor agonists (ANPA-0073), positioning itself for potential future success.
APJ receptor agonists activate the APJ (apelin) receptor, which plays a key role in regulating cardiovascular function, blood pressure, and glucose metabolism. APJR agonists are being explored for treating conditions like heart failure, hypertension, pulmonary hypertension, and type 2 diabetes, due to their ability to improve heart function, promote vasodilation, and enhance glucose and lipid metabolism. Structure’s ANPA-0073 is currently in early phase 2 trials just like its strongest competitor Azelaprag developed by BioAge Labs.
While the market is competitive, Structure’s focus on safety and oral formulations could give it a foothold in the growing weight loss drug sector.
🔸 AstraZeneca eyes oral GLP-1 leadership with ECC5004
AstraZeneca’s Farxiga, a major revenue-generating drug for diabetes and heart failure, is set to lose patent protection around 2025, potentially losing market share to emerging GLP-1 agonist drugs like Zepbound and Wegovy from Lilly and Novo Nordisk.
To address this, AstraZeneca acquired ECC5004 in November 2023, an oral GLP-1 receptor agonist from Eccogene. This strategic move, which involved an initial payment of $185M and potential milestone payments totaling up to $1.8B, positioned AstraZeneca to compete in the growing oral GLP-1 therapy market.
ECC5004 finished phase 1 clinical trials, with promising results indicating good tolerability and reductions in both glucose levels and body weight across various doses. AstraZeneca is now advancing ECC5004 into phase 2b studies, which could significantly boost its market value if successful. The phase 2b trials are set to begin on October 1 and 8, 2024.
🔸 Boehringer focuses on obesity and liver disease
Survodutide (BI 456906), developed by Boehringer Ingelheim, is a dual agonist targeting both the GLP-1 and glucagon receptors. This drug, which has received EMA PRIME and FDA Fast Track designations, is being explored for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and obesity (with a BMI ≥ 27 kg/m²).
Derived from the natural gut hormone oxyntomodulin, Survodutide is designed to regulate key metabolic functions by simultaneously activating the GLP-1 and glucagon receptors. Currently in phase 2 trials for MASH and phase 3 trials for obesity, Survodutide represents an advancement in Boehringer’s cardiometabolic disease R&D portfolio.
While Novo and Lilly are also pursuing GLP-1 treatments for MASH, Pfizer recently discontinued its candidate, danuglipron (PF-06882961), after a phase 1 trial, leaving fewer competitors in the space, suggesting a possibly more favorable outlook for Survodutide.
🔸 Noom’s $149 GLP-1Rx promises affordable solutions
On Thursday, September 12, Noom, a digital health company, launched Noom GLP-1Rx offering compounded GLP-1 injections starting at $149, significantly lower than brand-name prices. This product combines the medication with Noom’s GLP-1 companion program, designed to address common challenges associated with GLP-1s, such as poor persistence and lean muscle loss.
The new offering includes a “taper-off guarantee,” aiming to provide a pathway to sustainable weight loss and reduce reliance on long-term medication. Noom’s approach also highlights the disparity in GLP-1 medication pricing in the U.S. compared to other countries and the impact of these inflated costs on accessibility.
The company also called for policymakers to address these price discrepancies and support compounding exemptions until brand-name prices align with those in more affordable markets. According to Noom’s press release, by integrating high-quality compounded medications with behavioral and lifestyle support, the company aims to tackle obesity more effectively and provide a comprehensive solution for long-term weight management.
I included this recent development in this deep dive because it has the potential to disrupt the GLP-1 market. This is mainly because Noom’s affordable compounded GLP-1s will increase accessibility, put pressure on pricing and possibly encourage other companies to explore similar approaches.
That being said, it is unclear whether Noom’s primary goal is to prioritize delivering affordable, safe, and effective treatments or if their approach is more focused on capitalizing on available regulatory opportunities for profit. While Noom claims to have partnered with an FDA-regulated 503B compounding pharmacy to ensure the highest quality and safety standards, the safety and efficacy of compounded medications are not as rigorously tested as brand-name drugs approved by the FDA.
Happy Sunday and thanks for reading Biotech Blueprint!
—Katerina Roznik, PhD
DISCLAIMER: This content is for informational purposes only. It should not be taken as legal, tax, investment, financial, or other advice. The views expressed here are my own and do not reflect the opinions of any company or institution.
DISCLOSURE: I have no business relationships with any company mentioned in this article.
Great review, this will be a space to follow for years to come!